Description and Brand Names

US Brand Name

Xolair

Descriptions

Omalizumab injection is used to treat moderate to severe persistent allergic asthma. It is used when a patient's asthma has not been controlled sufficiently on other asthma medicines. This medicine will not relieve an asthma attack that has already started.

Omalizumab injection is also used to treat chronic idiopathic urticaria (CIU) in patients who continue to have hives that are not controlled by an antihistamine.

Omalizumab is a medicine called an IgE blocker. IgE is short for immunoglobulin E. IgE is a substance that occurs naturally in the body in small amounts. This substance plays an important role in allergic asthma. When people with allergic asthma breathe in a year-round allergen, such as cat or dog dander, their bodies make more IgE. This may cause a series of reactions in your body that can lead to asthma attacks and symptoms. Omalizumab works by helping to block IgE.

This medicine is to be given only by or under the direct supervision of your doctor.

This product is available in the following dosage forms:

Powder for Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Use of omalizumab injection in children younger than 12 years of age is not recommended. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of omalizumab injection in the elderly.

Pregnancy

Information about this omalizumab-subcutaneous-route

Pregnancy Category

Explanation

All Trimesters

B

Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Asthma attack or

Bronchospasm (breathing problem), acute or

Other allergic conditions (besides asthma)—Should not be used for patients with these conditions.

Cancer, or history of or

Parasite infection—Use with caution. May make these conditions worse.

Proper Use

A nurse or other trained health professional will give you or your child this medicine. Omalizumab is given as a shot under your skin.

If you are receiving this medicine for asthma, you will receive omalizumab once every 2 or 4 weeks. Your dose will be determined by your IgE level, which your doctor will measure with a simple blood test before treatment begins, and your body weight. Based on your dose, your doctor will also tell you if you will need 1, 2, or 3 injections per dose. If you need more than 1 injection, each will be given in a different place on your body.

Omalizumab is not a rescue medication and should not be used to treat sudden asthma attacks. It is not a substitute for the medicines you are already taking. Never suddenly stop taking, or change the dose of your inhaled steroids or any other asthma medicine you are taking unless your doctor tells you to do so.

If you are receiving this medicine for chronic idiopathic urticaria, you will receive this medicine every 4 weeks.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Precautions

It is very important that your doctor check your or your child's progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood and other exams may be needed to check for unwanted effects.

If you stop receiving omalizumab injections, your symptoms can be expected to return.

You may not see immediate improvement in your asthma after omalizumab treatment begins. It takes time for the medicine to work. It is important to continue your omalizumab injections until your doctor tells you otherwise.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash, cough, chest tightness, shortness of breath, trouble breathing, wheezing, lightheadedness, dizziness, fainting, rapid or weak heartbeat, anxiety, flushing, itching, hives, feeling warm, swelling of the throat or tongue, throat tightness, hoarseness, or trouble swallowing after receiving this medicine.

A rare but serious condition called eosinophilia (increased white blood cells in the body) may occur while you are receiving this medication. A condition called vasculitis (inflammation of the blood vessels) may also be present. Eosinophilia can be serious and requires immediate medical attention. Tell your doctor right away if you or your child have worsening lung symptoms, rash or bruising of the skin, fever, chest pain, or burning, tingling, or numbness in the hands and feet after receiving this medicine.

Your doctor will ask you or your child to remain at the healthcare facility or clinic for at least 2 hours after each injection to watch for immediate side effects that can be serious.

Some patients who are receiving this medicine may have fever, rash, or muscle or joint pain. Tell your doctor right away if you or your child have any of these symptoms.

Using this medicine may increase your risk of getting certain cancers or infections. Talk to your doctor if you or your child have concerns about this risk.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Rare

Cough

difficulty with swallowing

dizziness

fast heartbeat

hives, itching, or skin rash

malignant tumor

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

tightness in the chest

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bleeding

blistering

body aches or pain

burning

chills

cold or flu-like symptoms

coldness

congestion

discoloration of the skin

dryness or soreness of the throat

feeling of pressure

fever

headache

hoarseness

itching

leg pain

lumps

muscle or joint pain

numbness

pain

pain or tenderness around the eyes and cheekbones

redness

runny nose

scarring

sore throat

soreness

stinging

stuffy or runny nose

swelling

tender, swollen glands in the neck

tenderness

tingling

ulceration

voice changes

warmth

Less common

Arm pain

blistering, crusting, irritation, itching, or reddening of the skin

body produces substance that can bind to drug making it less effective or cause side effects

cracked, dry, or scaly skin

earache

itching skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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